510(k) · Cleared
ClearedKolibri Image Guided Surgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Oct 19, 2004 as substantially equivalent to K014256 (Brainlab AG, 2002) and 1 other predicate after a 47-day review. Its family tree reaches back 2 generations to 1999. 1 of the 78 devices in its family, counting itself, has a Class I recall. 72 later devices descend from it.
- Decided
- Oct 19, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983831 (1999). 5 ancestors in all. 72 later devices descend from it, 3 citing it directly. 1 of the 78 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 1 generation backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- This deviceK042391 Kolibri Image Guided Surgery SystemBrainlab AG · 2004
- Descendant · cites it directly · 53 of its ownK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- Descendant · 2 generations on · 51 of its ownK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- Descendant · 2 generations on · 46 of its ownK100931 Mylabtwice, Model 6200Esaote, S.p.A. · 2010
- Descendant · 2 generations on · 35 of its ownK103152 6250 Ultrasound SytemsEsaote, S.p.A. · 2011
- Descendant · 2 generations on · 34 of its ownK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K092467 Vectorvision Cranial, Vectorvision Ent, Kolibri…2 generations on · 2010
Most influential descendants
Showing 5 of 72 · See all- K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · cites it directly53descendants
- K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A. · 2009 · 2 generations on51descendants
- K100931Mylabtwice, Model 6200Esaote, S.p.A. · 2010 · 2 generations on46descendants
- K1031526250 Ultrasound SytemsEsaote, S.p.A. · 2011 · 2 generations on35descendants
- K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −1 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| 0 (this device) | K042391 | Kolibri Image Guided Surgery System | Brainlab AG | 2004 | — |
| +1 | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | 2 |
| +2 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| +2 | K100931 | Mylabtwice, Model 6200 | Esaote, S.p.A. | 2010 | — |
| +2 | K103152 | 6250 Ultrasound Sytems | Esaote, S.p.A. | 2011 | — |
| +2 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014256 | Kolibri Igs SystemsSummary page 1…e Guided Surgery System / Instrument, Stereotaxic Product Code: H-AW CFR 882.4560 Predicate Devices: KolibriTM Image Guided Surgery System (K(014256) Catheter Introducer for the StealthStation System (K(022126) Device Classification Name: Instrument, Stereotaxic Regulatory C… | 2002 |
| * | K022126 | Catheter Introducer for the Stealthstation SystemSummary page 2…e system. by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device Catheter Introducer for the StealthStation System (K022126) and Kolibri Image Guided Surgery System (KO14256). Rev. 5 06.10.2004… | 2003 |
What descends from it? (72)
See all 723 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K081386 (Esaote, S.p.A., 2008) has gone furthest, with 53 descendants of its own.
- 6 other devices also cite its predicate K014256.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set being processed by the Kolibri computer workstation. The system is indicated for any medical condition in which the use of…
Read the full statement (175 words)
The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set being processed by the Kolibri computer workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.
Example image guided cranial surgery procedures include but are not limited to:
1. Tumor resections
2. Skull base surgery
3. Cranial biopsies
4. Craniotomies/Craniectomies
5. Pediatric Catheter Shunt Placement
6. General Catheter Shunt Placement
Example image guided ENT surgery procedures include but are not limited to:
1. Transphenoidal procedures
2. Maxillary antrostomies
3. Ethmoidectomies,
4. Sphenoidotomies./sphenoid explorations,
5. Turbinate resections
6. Frontal sinusotomies
7. Intranasal procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042391: Kolibri Image Guided Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042391
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026